Donanemab Could Be an Effective Early Alzheimer Disease Treatment
Donanemab may improve cognition in patients with early Alzheimer disease (AD), according to the results of a recent study.
The researchers examined how this treatment that targets a form of deposited amyloid-β (Aβ) peptide may improve disease progression in patients with AD, as the accumulation of Aβ is a distinct characteristic of the disease.
Included in the study were 257 patients, of which 131 were randomly assigned to receive donanemab while 126 received placebo intravenously every 4 weeks for 72 weeks. Those who received donanemab had 3 doses of 700 mg followed by 1400 mg for the duration of the study period.
To be included in the study, the participants had to have early symptomatic AD, as well as tau and amyloid deposition on positron-emission tomography. The score change of the Integrated Alzheimer’s Disease Rating Scale (iADRS) was the primary outcome. A lower iADRS score indicated an increased cognitive and functional impairment.
The results indicated that at 76 weeks, the participants who received donanemab had an iADRS score that was 6.86 less than the baseline score of 106, while those who received the placebo had a score that was 10.06 less than the baseline score of 106. In addition, the amyloid plaque level and global tau load had reductions of 85.06 centiloids and was 0.01 greater in the donanemab group than in placebo. Only participants in the donanemab group saw any amyloid-related cerebral edema or mostly asymptomatic effusions.
“In patients with early AD, donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed,” the researchers concluded. “Longer and larger trials are necessary to study the efficacy and safety of donanemab in AD.”
Mintun MA, Lo AC, Duggan Evans C, et al. Donanemab in early Alzheimers disease. NJEM. Published online March 13, 2021. doi: 10.1056/NEJMoa2100708